Pre-operative Therapy in Breast Cancer
Recruiting
- Conditions
- Breast Cancer
- Interventions
- Drug: pre-operative therapy
- Registration Number
- NCT05621564
- Lead Sponsor
- RenJi Hospital
- Brief Summary
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 488
Inclusion Criteria
- Female, Aged ≥18 years
- Histologically confirmed primary breast cancer
- Plan to receive pre-operative therapy
- Adequate organ function
Exclusion Criteria
- History of neurological or psychological disease, including epilepsy or dementia
- Not suitable to participate in this study judged by investigators
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description early breast cancer pre-operative therapy no requirements for therapy advanced breast cancer pre-operative therapy no requirements for therapy
- Primary Outcome Measures
Name Time Method Pathologic Complete Response at surgery ypT0 ypN0, ypT0/is ypN0
- Secondary Outcome Measures
Name Time Method Disease-free Survival From surgery until time of event up to 8 years Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause.
Objective response rate from the start of pre-operative treatment until the completion of surgery up to 6 months the rate of complete response and partial response
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, China